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Clinical Laboratory Testing Diagnostic Tests Emergency Use Authorization (EUA)

Mintz - Health Care Viewpoints

An Update on FDA’s Contribution to COVID-19 Diagnostic Testing

Back in the early days of the COVID-19 pandemic, we published a post outlining the different kinds of diagnostic tests that were being marketed and the different roles of the two main federal regulators that oversee the...more

Epstein Becker & Green

FDA Confirms That At-Home Collection Kits Are Not Authorized for Use with COVID-19 Tests

Epstein Becker & Green on

On March 16, 2020, FDA finalized its guidance titled Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency (the “Policy”). The Policy includes information and recommendations to assist...more

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